Skin Sparing Mastectomy and Immediate Breast Reconstruction With Latissimus Dorsi Flap After Neoadjuvant Chemotherapy and Radiotherapy (M-RIC)

Phase 2

• Conditions: Breast Carcinoma

• Registration Number: NCT01199354
• Lead Sponsor: Clinique Clementville

Brief Summary

The aim of the study is to evaluate the feasibility and morbidity of skin sparing mastectomy and immediate breast reconstruction with latissimus dorsi flap after neoadjuvant chemotherapy and radiotherapy in invasive breast carcinoma.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-09-08
• Study First Submitted QC: 2010-09-09
• Study First Posted: 2010-09-10
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-08
• Last Update Posted: 2011-06-09
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• Women < 75 year old
• Invasive breast carcinoma, indication for mastectomy
• Women Health Organization (WHO) score of 0 and 1, primary chemotherapy, external radiotherapy performed less than 8 week earlier...

Exclusion Criteria

• Women older than 75
• Metastatic breast carcinoma
• Antecedents of previously treated homolateral breast carcinoma
• Documented cancer progression
• Smoker at the moment of the indication surgery
• Known diabetes, neoadjuvant hormonal treatment...

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence of skin necrosis		To evaluate the incidence of skin necrosis in case of treatment with skin sparing mastectomy and immediate breas reconstruction with latissimus dorsi myocutaneous flap after neoadjuvant chemotherapy and radiotherapy.

Secondary Outcome Measures

Name	Time	Method
Rate of histological remission of the surgical specimen based on the anatomopathological examination

Trial Locations

Locations (9)

Polyclinique Urbain V; 🇫🇷 Avignon, France

Centre Léon Bérard; 🇫🇷 Lyon, France

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

Clinique Belledonne; 🇫🇷 Saint Martin d'Hères, France

Groupe Hospitalier Mutualiste Clinique les Eaux Claires; 🇫🇷 Grenoble, France

Clinique Clementville; 🇫🇷 Montpellier, France

Institut Paoli Calmettes; 🇫🇷 Marseille, France

Institut Claudius Regaud; 🇫🇷 Toulouse, France

CRLCC Val d'Aurelle; 🇫🇷 Montpellier, France